Purpose: To “provide an overview of how research is conducted for drug companies and how (one) might become involved.”

Content: This guide, written from the point of view of a site principal investigator contracting with a for-profit pharmaceutical sponsor, successfully covers a broad range of topics related to the implementation of clinical trials of pharmaceutical products. Practical considerations for identifying sponsors and potential studies, evaluating contracts, initiating studies, completing enrollment, and passing an audit are all covered, along with insightful introductions to regulatory issues, patient safety, ethical considerations, and societal and political issues affecting clinical research. Many substantive insights garnered from the author's own experience are included, and both the positive and negative aspects of conducting for-profit pharmaceutical research are fairly presented. Substantial background and resource information is included in 4 well-structured appendices.